The medical industry is under increasing legal pressure these days owing mainly to a consumer-friendly risk environment. This is evident from restrictive legislation and recent landmark cases, such as the PIP case, concerning a French company that supplied thousands of women with (allegedly) defective breast implants, and the Boston Scientific case, which dealt with pacemakers and cardioverter defibrillators. Reference is made to the European Commission that has recently started trialogue negotiations to revise the Medical Devices and Diagnostics Directives. The duties and responsibilities of notified bodies are further increased and specified. In many cases, this would create more work than is currently required by the so-called interim measures already imposed. As a result, costs for manufacturers would increase. Furthermore, the PIP case shows that not only manufacturers, but also notified bodies and hospitals/physicians are increasingly subject to claims across Europe, and the Boston Scientific case shows that the European Court of Justice extended the risk of liability and compensation of damages for manufacturers. Read the article (enclosed) that appeared in Pharmaceutical Market Europe.